SYN - Synthetic Biologics VCN-01 shows safety in phase 1 trial in head/neck cancer

Synthetic Biologics ( NYSE: SYN ) said VCN-01, in combination with AstraZeneca's Imfinzi (durvalumab), showed an acceptable safety profile and encouraging biological activity in patients with a type of head and neck cancer, as per initial data from a phase 1 trial.

The early stage study is evaluating VCN-01 in combination with durvalumab for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC).

VCN-01 had an acceptable safety profile when given with durvalumab in the sequential regimen (single dose of VCN-01 administered 14 days before the first dose of durvalumab; n=14), the company said in a Sept. 5 press release.

The most common treatment-related adverse events (TRAEs) were fever, flu-like symptoms and increases in liver transaminases (enzymes, high levels of which could indicate liver damage.

The company said TRAEs were dose-dependent, reversible and consistent with other adenovirus-based products.

The company noted that based on the data the recommended phase 2 dose is 1x1013 viral particles (vp)/patient.

"We look forward to leveraging our findings as we advance VCN-01 through clinical development and we remain on track to deliver on several value-driving milestones, including the initiation of our Phase 2 study in patients with metastatic pancreatic adenocarcinoma in the fourth quarter of 2022 and our Phase 2/3 study in retinoblastoma in the second half of 2023," said Manel Cascall?, general director of Synthetic Biologics' European subsidiary.

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